Sensura Flex

Basic Information

• Brand Name: Sensura Flex
• Primary DI: 05708932404020
• Version / Model: 11304
• Catalog Number: 11304
• Company Name: Coloplast A/S
• Labeler DUNS: 305524696
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2022-12-02
• Public Version: 1
• Public Version Date: 2022-12-12
• Public Version Status: New
• Public Device Record Key: 96b6169f-ca3b-4f7b-9728-ad20904825de

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EXB	COLLECTOR, OSTOMY	Gastroenterology, Urology	876.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48158	Intestinal ostomy base plate, convex	A non-sterile device designed with a convex surface intended to be applied and adhered to peristomal skin to facilitate correct positioning and anchorage of the flange of an intestinal ostomy bag (i.e., one-piece or exchangeable two-piece/multiple piece) and to protect the area from bodily waste contaminants. The convexity of the device is used to improve peristomal skin contact of a flush stoma or more typically a recessed stoma. It is typically self-applied by the patient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05708932404037	GS1	Shipper Box	24	In Commercial Distribution
Primary	05708932404020	GS1
Unit of Use	05701780065542	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Base Plate Precut Start Hole Size - mm 15
Device Size Text, specify			Base Plate Type Convex Light
Lumen/Inner Diameter	35	Millimeter
Device Size Text, specify			Base Plate Max Cut Size - mm 23
Device Size Text, specify			Coupling Size Diameter - in 1 3/8
Device Size Text, specify			Base Plate Max Cut Size - in 7/8
Device Size Text, specify			Base Plate Precut Start Hole Size - in 9/16